Medication distribution system

ABSTRACT

A unique medication distribution system for compliance packaging of medications, designed to contain each individual&#39;s unique daily medications and supplements and enhance the timely administration of the medications. The production and distribution of the system is automated and highly integrated with the database software as well as business software managed and operated by a pharmacy. The system comprises of a card made up of plastic, paper or composite materials with blister components containing the medication. The card can be bipartite or multipartite according to the medication needs of a user, with foldable side panels. An array of the timing corresponding to each medication is printed on the card. Corresponding to each medication is also an array listing the name of the doctor, the name of the medication and the rationale for its administration. A side panel may have sleeves or pockets containing salves, ointments, patches, lotions or milks, when prescribed to the user. A side panel may be customized to advertising targeting the market defined by individuals who take several medications in a day.

RELATED APPLICATION

This Application is a Divisional of related pending U.S. patentapplication Ser. No. 09/620,891 filed Jul. 21, 2000 entitled MEDICATIONDISTRIBUTION SYSTEM, which is incorporated herein by reference in itsentirety, and claims any and all benefits to which it is entitledtherefrom.

FIELD OF THE INVENTION

The present invention is related to medication distribution systems, inparticular compliance packaging of medications or supplements that makeit possible to confirm that a dispensation of a medication regimencustomized to an individual's daily needs has actually been adhered toduring the course of a day as prescribed by the practitioner.

BACKGROUND OF THE INVENTION

A major problem confronted by people, particularly the disabled,chronically ill, home bound and psychiatric patients on multiple drugs,is the implementation of the necessary drug regimen in a safe, accurateand a timely manner. During pharmacological training of nurses anddoctors, great emphasis is placed on the absolute necessity formaintaining prefect accuracy in the administration of medications.Errors and misuse can undermine the effectiveness of these drugs and canindeed be dangerous to the patient, causing fatal results and costingbillions of dollars annually to our national health care system. In manyinstances, the patient's drug regimen includes up to six or moremedications to be taken daily, each medication having its own time tableand dosage, and each with accompanying supplements, instructions andwarnings. The timing and dosage of medicines is subject to frequentchange and may vary from day to day, particularly among the elderlypatients. The effort to keep track of such a complexity of informationcan be confusing and threatening to the patient, causing distress andoften prolonging recovery.

There are numerous prior art examples of medication containers providedwith time reminder or calendar devices. Generally, the containers havereminder devices affixed to them which bear a plurality of indiciacorresponding to desired time periods. The indicia used on suchdispensers are an integral part of the dispensers and, if for somereason a different time schedule is desired, the dispenser is unusablefor such different schedule and a whole new dispenser/indicia packagemust be prepared for each new schedule. Charts currently in use bymedical professionals are often difficult for anyone outside theprofession to read and understand. Many patients are already disquietedsimply by being ill and can become additionally concerned and/orconfused with the added burden of having to follow the doctor's orders.Plastic box containers work only for those using relatively fewmedications; they do not accommodate a large multiplicity ofmedications, for example, 6 to 12 to be taken several times daily, 7days a week, and of course the medication must be in pill form to beplaced in the slots of the plastic containers. Systems such as these arenot useful for medications that are sensitive to light or air; neitherare they practical for the use of patches, salves, liquid medications ormedications that need to be refrigerated. The plastic box containers donot reinforce the name of the medication, the dosage, the usage orindication, and any pertinent information about the medication. In someinstances, licensed physicians must prescribe medication so that theproper dosages may be taken by the patient at uncommon althoughprescribed intervals (not simply daily) under proper supervision. Insuch a case it has been found that the devices to assist the user intaking the dosage are either not available or are not alterable to varythe dispensing time schedule in response to certain conditions which mayrequire a different regimen. It would be desirable to provide thephysician with a time-reminding and dispensing device, for particularpatients for his/her daily dosages. Also where medication is prescribedon a varying schedule in order for the patient to be slowly introducedto or withdrawn from an efficacious medication level, it would bedesirable to provide the physician with a variety of time-reminding anddispensing devices, so that the regimen for taking the medication wouldbe easily variable to reflect the elements of dosage quantity andfrequency of the various desirable stages.

One prior art U.S. Pat. No. 6,062,420 issued May 16, 2000 to Krouwel etal is an apparatus for dispensing pills from a blister pack in whichcavities containing pills are distributed.

A further prior art U.S. Pat. No. 4,126,247 issued Nov. 21, 1978 toMajka is an upright housing having a transparent side and a plurality ofcompartments positioned in rows and columns. Each column represents aday of the week and each row represents a week of a month. Eachcompartment is adapted to store a day's medication and a calendar on thetransparent side labels each compartment as a different day of themonth. A key-operated control device releases medication from aselection compartment to the opening through the bottom of thetransparent side of the housing. But this pill dispenser does notsuggest any system for storing the medication before use except manuallyby the user or someone for him, which is not free from error.

One prior art U.S. Pat. No. 5,431,450 issued Jul. 11, 1995 to Colemanteaches a chart or a board listing medications, dosages and times to betaken; its surface serving as a dry continuous basis, marked by amarker, subject to erasing and geared toward flexible daily use. Thereis a medication-recessed tray that organizes the user's medicines intoone central location. It has a calendar section having square boxes thatare to be marked after medication is ingested or applied. It has arefill column, where refill dates and other refill information isplaced. But this medication board does not guarantee an accurateingestion of medication as errors in scheduling, refilling, and markingare quite a possibility. Additionally, this medication board becomesvery vulnerable to user error, especially when the patient is himselfadministering the medication and is partially or more or lessdebilitated or infirm.

Another prior art U.S. Pat. No. Des. 375,526 issued Nov. 12, 1996 toLondino teaches an ornamental design for a calendar for a medicinereminder.

A further prior art U.S. Pat. No. 4,819,352 issued Apr. 11, 1989 toMaunand et al discloses a dosage calendar comprising at least two timescales; the units of the first scale being the day in the month or weekor else a fraction of a day in the month, week or day, and the secondscale having a number of unit elements with a value of seven or amultiple of seven, with at least one of the scales including arecognition mark which can be changed by the user during the treatment.These two scales, which are interchangeable and can also have unitelements in common, make it possible to identify three moments in timeby virtue of the recognition marks or signs: the start of the treatment,the time of the last dose and the time of the next dose. However, thecalendar does not teach an automatic distribution system for theadministration of drugs. The scales have to be adjusted by the patientsor the caretakers and the adjustment is subject to error.

A further prior art, U.S. Pat. No. 4,974,729 issued Dec. 4, 1990 toSteinnagel discloses a calendar type dispenser in association with aseparable indicia means, the combination comprising a reminder systemfor the patient to take a particular dosage of medication.

One prior art, U.S. Pat. No. 5,031,937 issued Jul. 16, 1991 to Nellhausteaches a pictorial system to assist in the administration ofmedication, The picture stamps, each reflecting a unit of a medication,are to be pasted into discrete spaces of a sheet, card, label or boxcover divided into columns and rows identified by icons for the time ofday one or more units of the medication are to be taken. However, thissystem involves associating the appearance of the drug with its name andstrength, thereby enhancing the risks of improper administration ofmedication by the user. It also creates the problem of reproduction ofthe visual depictions of the medications.

ADVANTAGES AND SUMMARY OF THE INVENTION

In view of the above, a principal object and advantage of this inventionis to provide a convenient and inexpensive means of supplying a dailyregimen of multiple medications and/or health supplements organized bytime of day and period.

It is a further object and advantage of this invention to provide a timereminding system.

A further object and advantage of the present invention is to provide amedication distribution system which assists in self-administration orthe giving of medications while reducing the risks of improper ingestionof medication or poor compliance that could result in seriousconsequences.

Another object and advantage of the present invention is to provide ameans for assessing each patient's daily regimen, allowing a physicianor other health practitioner to monitor compliance, the ability of anindividual to take medications and supplements as prescribed.

Yet another object and advantage of the present invention is to providea form to give the patient specific information relative to themedications and supplements ingested.

It is also an object and advantage of the present invention tocontributes to the success of scientific evaluation of the use ofmedications (evidence based medicine) by facilitating a clearunderstanding of compliance.

Thus, a preferred embodiment of the system and method of the presentinvention includes compliance packaging of medications and supplementsin a distribution system for individuals taking multiple medicationsduring the course of a day so that compliance with a prescribed regimenis enhanced. The system comprises a card made of paper, plastic orcomposite material studded with blister pack components. The card may bebipartite or multipartite, customized to an individual's dailymedication and supplement requirements. The repositories of medicationsand supplements are adhered either directly or indirectly (with tape,glue or other means) to the card. Pills, tablets and capsules arearranged in an array or in a circular or oval fashion, corresponding totime of ingestion. The side panels may have sleeves or pockets, whenneeded by the user, containing salves, patches, ointments and otherpharmaceutical products. The card has printed on it the name of theuser, the day and date for which it is to be used, the timing andquantity and amount of each dose, the name of the prescribing physician,the appropriate identification information for pharmacy andprescription, as well as pertinent therapeutic information.

The method of the present invention also includes, in a most preferredembodiment, “web based” information input, database management, androbotics designed to fill each medication distribution system card orsystem with medications and supplements as well as to orchestrate theprinting of each system. Security will be engineered at all levels ofsoftware design and product production.

In a preferred embodiment, the method of the present invention includesa website in which, optionally and as may be desirable or indicated, thepharmacists, physicians, and patients have access to the website, suchas to different portions thereof or with different levels of security.In the preferred embodiment, the website can be operated by a pharmacyresponsible for the management of the databases for an individual'sdaily medications, patient records, practitioner's prescriptions,pharmaceutical operations, and the production and distribution of systemof the present invention. The website is equipped with business softwarefor handling billing and ordering, and analyzing demand and supply. Itis linked with a drug interaction database. The site is coordinated anddirected with the help of Mechatronic Engine (Robotic automation withdatabase interface). It will be understood, however, that while themechanism for implementation of such paradigm shift in thepharmaceutical industry can be modified as desired or considered mosteconomically or otherwise feasible, any variations in the descriptionsherein will be considered within the scope of the present invention.

Numerous other advantages and features of the present invention willbecome readily apparent from the following detailed description of theinvention and the embodiments thereof, from the claims and from theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a foldable card, containing anarray of medication repositories embodying the principles of thepreferred embodiment of the present invention.

FIG. 2 is a representative section of the side panel of the device ofFIG. 1.

FIG. 3 is a plan view of an alternate preferred embodiment of thepresent invention shown in FIG. 1, with the medication repositoriesarranged in a circular or oval fashion.

FIG. 4 is the schematic representation of the operational mechanism andoverall administration of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The description that follows is presented to enable one skilled in theart to make and use the present invention, and is provided in thecontext of a particular application and its requirements. Variousmodifications to the disclosed embodiments will be apparent to thoseskilled in the art, and the general principals discussed below may beapplied to other embodiments and applications without departing from thescope and spirit of the invention. Therefore, the invention is notintended to be limited to the embodiments disclosed, but the inventionis to be given the largest possible scope which is consistent with theprincipals and features described herein.

It will be understood that in the event parts of different embodimentshave similar functions or uses, they may have been given similar oridentical reference numerals and descriptions. It will be understoodthat such duplication of reference numerals is intended solely forefficiency and ease of understanding the present invention, and are notto be construed as limiting in any way, or as implying that the variousembodiments themselves are identical.

FIG. 1 is a representative schematic drawing of a preferred embodimentof the device 100 showing a time reminding and dispensation system formedications and supplements. The system 100 comprises of a card 116 madeup of paper, plastic or composite materials with blister packcomponents. It may be bipartite or multipartite, foldable at the folds110 and may vary in size to meet the medication needs of an individualpatient. The repositories 106 may be blister packs, pockets, envelopesor medications and supplements adhered either directly or indirectly(with tape, and adhesive film or other device) to the card 116.

The head 112 of the main panel 118 has the user/patient's name as wellas the day and date for which the card 116 is created. The date and dayare important for the user to keep track of his/her medication over aperiod of time. The array 114 on the main panel 118 lists the name ofthe medication and the quantity prescribed, name of the physician andthe reason for which the medication is prescribed. This information isprovided to keep the patient or the caregiver educated as well as toassist them in using the website for having a new prescription or givinga new order. Also, such information is needed the most in case ofemergencies. Additionally, it will be understood that the required8-digit reference code for the particular prescription must be indicatedalongside each of the medication repositories 106.

The repositories of medication 106 in the main panel 118 are arranged inan array in sequential order i.e. the order the medication has to betaken in succession during the passage of a day. The timing of themedication is printed on the tabs 108. The timing can be set by hours ormeal times or with other medications. When a medication is ingested asit becomes due, the tab 108 is pulled to indicate that the medicationfor that particular hour has been ingested or applied.

FIG. 2 is a representative section of the side panel 102 of the device100 of FIG. 1. It illustrates the sleeves or pockets 302 to putointments, salves, patches, eye drops, lotions, milks or otherpharmaceutical forms of medications or supplements. The sleeves orpockets 302 can be made up of polythene or other suitable material.

Also, the side panel 102 of the card 116 can be used by the user forputting important notes such as the doctor's phone number or noting anyadverse effects caused by the ingestion of a medication, etc. The sidepanel 104 of the card 116 provides a unique opportunity for graphic andtext advertising customized for a market defined by those individualtaking several medications or supplements daily.

FIG. 3 is a preferred alternate embodiment of the invention shown isFIG. 1., illustrating a time reminding and dispensation system formedications and supplements. The system 200 comprises of a card 216 madeup of paper, plastic and composite materials with blister packcomponents. It may be bipartite or multipartite, foldable at the folds210 and may vary in size to meet the medication needs of an individualpatient. The repositories may be blister packs, pockets, envelopes ormedications and supplements adhered either directly or indirectly (withtape, and adhesive film or other device) to the card 216.

The header 212 on the main panel 218 has the user/patient's name, theday and date for which the card 216 is created. The date and day areimportant for the user to keep track of his/her medication. The timing208 of the medication is printed on the respective repository 206. Thetiming can be set by hours or meal times or with other medications. Whenthe time is due the blister 208 is pushed and the medication isingested.

The repositories of medication 206 are arranged in a circular or ovalfashion on the main panel 218, in a sequential order, clockwise oranticlockwise, in which the medications have to be taken in successionduring the passage of a day. The array 214 lists the name of themedication and the quantity prescribed, the name of the physician andthe rationale for which the medication is prescribed. This informationis provided to keep the patient or the caregiver educated as well as toassist them in using the website for having a new prescription or givinga new order. Also, such information is needed the most in case ofemergencies.

The side panel 202 of the card 216 has sleeves for putting for puttingpatches, salves, ointments, eye drops or other pharmaceutical forms ofmedications. Also, the side panel 202 of the card 216 can be used by theuser for putting important notes such as the doctor's phone number ornoting any adverse effects caused by the ingestion of a medication, etc.

FIG. 4 is the schematic representation of the operational mechanism andoverall administration of the present invention. The device of FIG. 1 isan industrial product whose production, distribution and marketing canbe internet-based or assisted. The operational mechanism will be managedand directed by a website overseen by a pharmaceutical company,insurance company, healthcare maintenance organization, provider networkor other administrative scheme. FIG. 4 shows a block diagram of thesame. The internet website 402 will be designed to allow physicians andpharmacists to enter a patient's daily medication prescription directly,and to allow patients to preview their system and to add over thecounter supplements.

The website 402 is protected by and interfaced with a firewall 404 orother server means which allows exclusive and selective access by thepractitioners and their patients. The website 402 is loaded with theDatabase of Patients Prescription 406, the Practitioner Database 410,Drug Interaction Database 408, and Business Software for billing,orders, and Demand and Supply analysis 412. All these Databases (406,410, 408, 412) are directed and coordinated by a Mechatronic Engine(Robotic automation with database interface) 416 and are led into theproduction of the medication distribution system 418. The MechatronicEngine 416 in turn is connected with Pharmaceutical and SupplementSupply 414. The Distribution 420 of the system 418 is then done at theretail level to various pharmacies.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the present invention belongs. Although any methods andmaterials similar or equivalent to those described can be used in thepractice or testing of the present invention, preferred methods andmaterials are now described. All publications and patent documentsreferenced in the present invention are incorporated herein byreference.

While the principles of the invention have been made clear inillustrative embodiments, there will be immediately obvious to thoseskilled in the art many modifications of structure, arrangement,proportions, the elements, materials, and components used in thepractice of the invention, and otherwise, which are particularly adaptedto specific environments and operative requirements without departingfrom those principles. The appended claims are intended to cover andembrace any and all such modifications, with the limits only of the truepurview, spirit and scope of the invention.

1. A medication and healthcare supplements distribution system to ensurecompliance packaging, customized to the needs of an individual patientand industry supported so as to enable the user to take medications asprescribed on a daily basis.
 2. The medication distribution system ofclaim 1 further comprising web-based input means.
 3. The medicationdistribution system of claim 2 comprising an industrial product whoseproduction, distribution and marketing is internet-based.
 4. Themedication distribution system of claim 2 in which the operationalmechanism is responsible for the management of a database consisting ofan individual's daily medications, prescriptions and supplement needs.5. The medication distribution system of claim 2 further comprising aninternet website designed to allow physicians and pharmacists to enterpatient's daily medication prescription.
 6. The medication distributionsystem of claim 5 in which the website is loaded with one or more of thefollowing: the Database of Patient Prescription, the PractitionerDatabase, Drug Interaction Database, and Business Software for billing,orders, and Demand and Supply analysis.
 7. The medication distributionsystem of claim 5 directed and coordinated by a Mechatronic Engine,optionally comprising robotic automation with database interface.
 8. Themedication distribution system of claim 2 further comprising means forcommunication of system data to patient or physician based medicalrecord systems.
 9. The medication distribution system of claim 1especially adapted for monitoring of compliance.